Investigation of Metformin for the Prevention of Progression of Precursor Multiple Myeloma

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

Assessed by using the serum-protein electrophoresis

8 participants in the metformin arm and 6 participants in the control arm did not have analyzable m-protein data.

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secondary · NOT_POSTED

Serum Free Light Chains Change by Mass Spectrometry

Source null

→

secondary · NOT_POSTED

Hemoglobin Concentrations Change

Source null

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secondary · NOT_POSTED

Hemoglobin A1c (HbA1c) Concentrations Change

Source null

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secondary · NOT_POSTED

Molecular Evolution of CD138+ Cells

Source null

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secondary · NOT_POSTED

Molecular Evolution of Immune Cells (CD138- or CD45+)

Source null

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Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

PROMIS · Changes in PROMIS Global Health Summary Score v1.2

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id: clinical-indications-draft-1
disease state id: ds-monoclonal-gammopathy-of-undetermined-significance
nct id: NCT04850846
qol key: qol-0007
source section id: NCT04850846-om-0007
source outcome index: 7
instrument: PROMIS
instrument basis: matched 'promis' in the study's own wording
scale title: Changes in PROMIS Global Health Summary Score v1.2
measure definition: Source null
time frame: Baseline to 6-months
analysis role: secondary
reporting status: NOT_POSTED
higher is better: Source null
direction quote: Source null
population note: Source null
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z

Open the exact result →

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-monoclonal-gammopathy-of-undetermined-significance
nct id: NCT04850846
trial label: Investigation of Metformin for the Prevention of Progression of Precursor Multiple Myeloma
applicability: narrower
applicability note: Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: registry-condition-search
discovery note: Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count: 6
harms Count: 2
qol Count: 1

outcomes

release id
clinical-indications-draft-1
disease state id
ds-monoclonal-gammopathy-of-undetermined-significance
nct id
NCT04850846
outcome key
om-0000
source section id
NCT04850846-om-0000
source outcome index
0
endpoint
(M-)Protein Concentrations Change
endpoint definition
Assessed by using the serum-protein electrophoresis
time origin
Baseline to 6-months
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
8 participants in the metformin arm and 6 participants in the control arm did not have analyzable m-protein data.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-monoclonal-gammopathy-of-undetermined-significance
nct id
NCT04850846
outcome key
om-0001
source section id
NCT04850846-om-0001
source outcome index
1
endpoint
Serum Free Light Chains Change by Mass Spectrometry
endpoint definition
Serum Free Light Chains Change by Mass Spectrometry
time origin
Baseline to 6-months
analysis role
secondary
reporting status
NOT_POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-monoclonal-gammopathy-of-undetermined-significance
nct id
NCT04850846
outcome key
om-0002
source section id
NCT04850846-om-0002
source outcome index
2
endpoint
Hemoglobin Concentrations Change
endpoint definition
Hemoglobin Concentrations Change
time origin
Baseline to 6-months
analysis role
secondary
reporting status
NOT_POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-monoclonal-gammopathy-of-undetermined-significance
nct id
NCT04850846
outcome key
om-0003
source section id
NCT04850846-om-0003
source outcome index
3
endpoint
Hemoglobin A1c (HbA1c) Concentrations Change
endpoint definition
Hemoglobin A1c (HbA1c) Concentrations Change
time origin
Baseline to 6-months
analysis role
secondary
reporting status
NOT_POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-monoclonal-gammopathy-of-undetermined-significance
nct id
NCT04850846
outcome key
om-0004
source section id
NCT04850846-om-0004
source outcome index
4
endpoint
Molecular Evolution of CD138+ Cells
endpoint definition
Molecular Evolution of CD138+ Cells
time origin
Baseline to 6-months
analysis role
secondary
reporting status
NOT_POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-monoclonal-gammopathy-of-undetermined-significance
nct id
NCT04850846
outcome key
om-0005
source section id
NCT04850846-om-0005
source outcome index
5
endpoint
Molecular Evolution of Immune Cells (CD138- or CD45+)
endpoint definition
Molecular Evolution of Immune Cells (CD138- or CD45+)
time origin
Baseline to 6-months
analysis role
secondary
reporting status
NOT_POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-monoclonal-gammopathy-of-undetermined-significance
nct id
NCT04850846
outcome key
om-0000
arm key
OG000
arm label
Metformin
regimen
Randomly assigned participants receive a stepped dose escalation until target daily dose of 1500mg Metformin XR is reached (3 x 500mg pills/day). The intervention duration will last an additional 6 months. Metformin Extension: Participants will have the option of unblinding at the end of their 6months treatment and those who were randomly assigned to the metformin experimental arm can continue taking metformin if they opt in. The extended intervention duration will last an additional 6 months. (1500mg Metformin XR or highest tolerated dose ) Metformin XR: Orally by mouth
analyzed count
22
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04850846-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-monoclonal-gammopathy-of-undetermined-significance
nct id
NCT04850846
outcome key
om-0000
arm key
OG001
arm label
Placebo
regimen
Randomly assigned participants receive a stepped dose escalation until target daily dose of 3 pills/day is reached. The intervention duration will last 6 months. Placebo: Orally by mouth
analyzed count
24
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04850846-om-0000#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-monoclonal-gammopathy-of-undetermined-significance
nct id
NCT04850846
harm key
EG000
source section id
NCT04850846-ae
event group key
EG000
event group label
Metformin
serious affected
1
serious at risk
30
other affected
26
other at risk
30
frequency threshold
5
collection period
Adverse events were collected from the time of informed consent, through 30 days after the last dose of study drug, up to 7 months for the initial randomized placebo-controlled phase and up to 13 months for participants who continued onto the extension phase
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-monoclonal-gammopathy-of-undetermined-significance
nct id
NCT04850846
harm key
EG001
source section id
NCT04850846-ae
event group key
EG001
event group label
Placebo
serious affected
1
serious at risk
30
other affected
18
other at risk
30
frequency threshold
5
collection period
Adverse events were collected from the time of informed consent, through 30 days after the last dose of study drug, up to 7 months for the initial randomized placebo-controlled phase and up to 13 months for participants who continued onto the extension phase
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

release id
clinical-indications-draft-1
disease state id
ds-monoclonal-gammopathy-of-undetermined-significance
nct id
NCT04850846
qol key
qol-0007
source section id
NCT04850846-om-0007
source outcome index
7
instrument
PROMIS
instrument basis
matched 'promis' in the study's own wording
scale title
Changes in PROMIS Global Health Summary Score v1.2
measure definition
Source null
time frame
Baseline to 6-months
analysis role
secondary
reporting status
NOT_POSTED
higher is better
Source null
direction quote
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

setting source links

Preserved source evidence · Not medical advice